SEMISOLIDTOPICAL DOSAGE FORM

HANDBOOK OF PHARMACEUTICAL

GENERIC DEVELOPMENTS E M IS OLIDSVOLUME III - Part One
Generic Development Topical Dosage Forms

HANDBOOK OF PHARMACEUTICAL
GENERIC DEVELOPMENT
Handbook of Pharmaceutical
Generic Development 24 Volume Series
Handbook of Pharmaceuticalhandbooks@locumusa.com
http://www.l o c u m u s a . c o mGeneric Development

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Handbook of Pharmaceutical
Generic Development SeriesCompiled by :J. D. BLOCK
BSc. MPS. D/PHARM.
Research Director Generic & Innovative Drug Development Division, Locum International Group.
Science Editor - International Journal of Generic Drugs & International Journal of Drug Development
School of Pharmacy University of the Witwatersrand and Witwatersrand Technikon
Johannesburg RSA.

Edited:IAGIM Scientific Committee
Review Process :Generic & Innovative Drug Development Division
Research Center
Locum International Research

Handbook of Pharmaceutical Generic Development

Vol. 1 - Tablets

Part I (Development) & Part II (Model ANDA or EU Dossier)Handbook of Pharmaceutical Generic Development

Vol. 2 - Capsules

Part I (Development) & Part II (Model ANDA or EU Dossier)Handbook of Pharmaceutical Generic Development

Vol. 3 - Semisolids

Part I (Development) & Part II (Model ANDA or EU Dossier)Handbook of Pharmaceutical Generic Development

Vol. 4 - Liquids

Part I (Development) & Part II (Model ANDA or EU Dossier)Handbook of Pharmaceutical Generic Development

Vol. 5 - SG Capsules

Part I (Development) & Part II (Model ANDA or EU Dossier)Handbook of Pharmaceutical Generic Development

Vol. 6 - e-SOPs / SOPs.

Part I (Development) & Part II (Model ANDA or EU Dossier)Handbook of Pharmaceutical Generic Development

Vol. 7 - Suspensions

Part I (Development) & Part II (Model ANDA or EU Dossier)Handbook of Pharmaceutical Generic Development

Vol. 8 - Eye & Nose

Part I (Development) & Part II (Model ANDA or EU Dossier)Handbook of Pharmaceutical Generic Development

Vol. 9 - Aerosols MDIPart I (Development) & Part II (Model ANDA or EU Dossier)Handbook of Pharmaceutical Generic Development

Vol. 10 -Tablets CR/MRPart I (Development) & Part II (Model ANDA or EU Dossier)Handbook of Pharmaceutical Generic Development

Vol. 11 -Capsules ER

Part I (Development) & Part II (Model ANDA or EU Dossier)Handbook of Pharmaceutical Generic Development
Handbook of Pharmaceutical Generic Development
Part I (Method Validation) & Part II (Analytical Methods 1994-2003)

Handbook of Pharmaceutical Innovative Development
Handbook of Pharmaceutical Innovative Development
Handbook of Pharmaceutical Innovative Development
Handbook of Pharmaceutical Drug Development (1-5)

Vol. 12 - Tablets Oral DR
Vol. 13 - Analytical(Top 50 Generic Assay Methods)

Vol. 14 - Tablets Oral
Vol. 15 - Capsules Oral
Vol. 16 - Suspensions Oral
Vol. 17 - MF and MMI(Master Formula & Manufacturing Instructions Parts 1 - 5)

Handbook of Pharmaceutical Drug Development (6-10)

Vol. 18 - MF and MMI(Master Formula & Manufacturing Instructions Parts 6 - 10)

Handbook of Pharmaceutical Innovative Development

Vol. 19 - SOPs/PAI-Checklist

Part I, Part II & Part III.(Development, Manufacturing & Engineering)

Handbook of Pharmaceutical Drug Development

Vol. 20 - Sterile Injections

Available either on Online, CD ROM or via electronic mail attachment.
Additional Drug Specific Volumes in Preparation. An on-going electronic and print seriespp
ppp
Handbook of Pharmaceuticalhandbooks@locumusa.com
http://www.l o c u m u s a . c o mGeneric Development

SEMISOLIDTOPICAL DOSAGE FORM

Electronic < Handbook Series ofPharmaceutical Generic Development
ISSN 0793 8667 - Electronic Version
Handbook Development 24 Volume Series
ISSN Series Number 0793 761X - Electronic Version

Handbook of Pharmaceutical Generic Development

Vol. 1 - Tablets

Part I (Development) & Part II (Model ANDA or EU Dossier)Handbook of Pharmaceutical Generic Development

Vol. 2 - Capsules

Part I (Development) & Part II (Model ANDA or EU Dossier)Handbook of Pharmaceutical Generic Development

Vol. 3 - Semisolids

Part I (Development) & Part II (Model ANDA or EU Dossier)Handbook of Pharmaceutical Generic Development

Vol. 4 - Liquids

Part I (Development) & Part II (Model ANDA or EU Dossier)Handbook of Pharmaceutical Generic Development

Vol. 5 - SG Capsules

Part I (Development) & Part II (Model ANDA or EU Dossier)Handbook of Pharmaceutical Generic Development

Vol. 6 - e-SOPs / SOPs.

Part I (Development) & Part II (Model ANDA or EU Dossier)Handbook of Pharmaceutical Generic Development

Vol. 7 - Suspensions

Part I (Development) & Part II (Model ANDA or EU Dossier)Handbook of Pharmaceutical Generic Development

Vol. 8 - Eye & Nose

Part I (Development) & Part II (Model ANDA or EU Dossier)Handbook of Pharmaceutical Generic Development

Vol. 9 - Aerosols MDIPart I (Development) & Part II (Model ANDA or EU Dossier)Handbook of Pharmaceutical Generic Development

Vol. 10 -Tablets CR/MRPart I (Development) & Part II (Model ANDA or EU Dossier)Handbook of Pharmaceutical Generic Development

Vol. 11 -Capsules ER

Part I (Development) & Part II (Model ANDA or EU Dossier)Handbook of Pharmaceutical Innovative Development

Vol. 12 - Semisolids

Handbook of Pharmaceutical Generic Development

Vol. 13 - Analytical

Part I (Method Validation) & Part II (Analytical Methods 1994-2003)(Top 50 Generic Assay Methods)

Handbook of Pharmaceutical Innovative Development

Vol. 14 - Tablets Oral DR

Handbook of Pharmaceutical Innovative Development

Vol. 15 - Suspensions Oral

Handbook of Pharmaceutical Innovative Development
Handbook of Pharmaceutical Innovative Development
Handbook of Pharmaceutical Innovative Development
Handbook of Pharmaceutical Innovative Development

Vol. 16 - Capsules Oral
Vol. 17 - Master FormulaVol. 18 - Master processes
Vol. 19 - SOPs/PAI-Checklist

Part I, Part II & Part III.(Development, Manufacturing & Engineering)
Available either on Online, CD ROM or via electronic mail attachment.
Additional Drug Specific Volumes in Preparation An on-going electronic and print seriespp
ppp
Handbook of Pharmaceuticalhandbooks@locumusa.com
http://www.l o c u m u s a . c o mGeneric Development

SEMISOLIDTOPICAL DOSAGE FORM

HANDBOOK OF
PHARMACEUTICAL
GENERIC DEVELOPMENT

Semisolid

TOPICAL DOSAGE FORM
VOLUME IIISEMISOLID-Part ONE

DOSAGEF O R M

Jeremy D. Block
B.Sc. MPS. D/Pharm.

International Euro Edition.
L O C U M

P U B L I S H I N G

H O U S E

handbooks@locumUSA.com / handbooks@locumEURO.com
Locum Publishing House - Israel Locum Pharmaceutical Publishers - USA Locum International Publishers - Cape Town

Handbook of Pharmaceuticalhandbooks@locumusa.com
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Handbook ofPharmaceuticalG e n e r i cDevelopment

Innovative SeriesPartOneSemis olids

DRUG Development

Copyright © 1994-01 - Locum Publishing
House Inc.

All Rights Reserved.

Neither this book nor any part may be
reproduced or transmitted in any form orby any means, electronic or mechanical,including photocopying, microfilming andrecording, or by any information storage
and retrieval system,without thepermission of the publishers.
Locum InternationalPublishers

Handbook of PharmaceuticalA

L o c u m

H o u s e

handbooks@locumusa.com
http://www.l o c u m u s a . c o m

P u b l i c a t i o n

Generic Development

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HPDD Innovative Series - Semisolid Dosage Forms
First and Second International Edition - 01/02.
First and Second edition published and distributed in UK, US, EU, RSA, Israel and Japan inNovember 1996-9: by Locum International Publishing House (Houston, Israel, South Africa).
Third International Edition - 03 (First Print).
Second printing published and distributed in UK, US, EU, Israel, Asia, and Japan inFebruary 2000 by Locum International Publishing House (Houston, Israel, South Africa) inHard Cover; Soft and Spiral Cover; Electronic Diskette; and e-mail attachment versions. All
print and electronic versions identical in content and format.
Copyright © 1995 - 2000, Handbook of Pharmaceutical Generic Development.
Text Copyright © 1995 - 2000, Handbook of Pharmaceutical Generic Development.
Illustration copyright © 1995 - 2001, Handbook of Pharmaceutical Generic Development.
Locum International Publishing House PO Box 874, 50 Gilad Street Kochav Yair 44864
Israel. - All right reserved.

ISBN 0793 873X
ISBN 0793 8748 - Electronic Version (Diskette, CD ROM, and Online version)
Handbook Development 24 volume series.
General ISSN Series number 0793 7407
General ISSN Series number 0793 7792 - Electronic Issue (Diskette, CD ROM andOnline version are identical in size and content to the printed hard or soft coverversion.)
Duplication: No part of this publication may be reproduced, stored in a retrieval
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Handbook of Pharmaceutical

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SEMISOLIDTOPICAL DOSAGE FORMEDITORIAL PREFACE
Handbook of Generic Drug Development - Semisolid Dosage Forms

This handbook represents the third International Edition for Europe of the ongoing
24 volume series of Generic Drug Development and appears under thecumulative title of the Handbook series of Generic Drug Development. The ongoingseries is updated annually at the end of each year. This is an ongoing process as
new data, specifications and process techniques are added on a continual andexpanding basis. This handbook is fact, never fully complete, as each new annualedition brings an enlarged and extended profile in the drug development process, aswell as new agency rules, guidelines and guidance to industry which continue to be
added year by year as the global product data base expands. Currently over 150
scientific publications and drug development conferences are annually referenced in
the 24 volume Handbook series of Generic Drug Development.
This mammoth task presents a continual ongoing commitment by the scientificreview committee to the improvement of the technical databases and the productspecific drug development requirements and know-how technology accessed
through the world wide IAGIM joint ventures and know-how projects currently active
in over 15 countries.
The Handbook is available in electronic format (Online and CD ROM) and the eformat is up-dated annually to association members of IAGIM.

This third international edition of the Handbook has been redesigned and updated
to meet the January 1999 Guidance for Industry - Organization of an Abbreviated
New Drug Application and an Abbreviated Antibiotic Application as well as all current
approved and draft FDA guideline requirements of the Center of Drug Evaluation
and Research (CDER) up to June 2001.
Editor-in-Chief.

ISSN 0793 873X

An on-going series
Additional Volumes in Preparation

General Series ISSN
0793 7407
Electronic Series ISSN 0793 7792

0793 7407
International Print Edition

ppp
LOCUM

ppp

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Acknowledgments
I.A.G.I.M. (R&D) Foundation.

I.A.G.I.M. Members (1994 - 2000).
Contributions - Generic & Research Firms
Associate Universities, Technicons and Consultants.
Handbook Series Coordinating Committee.
International Journal of Drug Development.
Journal of Pharmaceutical Development.
International Journal of Generic Drugs.
I.A.G.I.M. Drug Development Archives
Locum International Archives.
FDA/OGD/CDER Maryland
Guides and Guidelines
Library of Congress.
AIC Conferences.
Editorial Board.
Pharm. Eur.
USP/NF.
USPC.
BP.
°To Doribelle
for her years of support and help
to Sean for his expert knowledge on computerization
to David and Ari for running the project's computersand lastly to Pat for his inestimablecontribution.

Third International Edition.
2000

L O C U M

P U B L I S H I N G

H O U S EÍ°ÎÏÐÍ°Î

Handbook of Pharmaceuticalhandbooks@locumusa.com
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